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A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
Sponsor: Avidity Biosciences, Inc.
Summary
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)
Key Details
Gender
All
Age Range
16 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-06-10
Completion Date
2028-07
Last Updated
2026-05-29
Healthy Volunteers
No
Conditions
Interventions
AOC-1020
Placebo
Placebo
Placebo will be administered by intravenous (IV) infusion.
Locations (46)
University of California Irvine
Orange, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Calgary - Cumming School of Medicine
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Genge Partners Inc
Montreal, Quebec, Canada
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone
Marseille, France
CHU de Montpellier - Hopital Gui de Chauliac
Montpellier, France
CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires
Nice, France
AP-HP Hopital Pitie-Salpetriere
Paris, France
Universitaetsklinikum Bonn
Bonn, Germany
Georg-August-Universitaet Goettingen Stiftung oeffentlichen Rechts Universitaetsmedizin Goettingen
Göttingen, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Fondazione Serena ETS - Centro Clinico NeMO Milano
Milan, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, Italy
National Hospital Organization Osaka Toneyama Medical Center
Osaka, Japan
The University of Osaka Hospital
Osaka, Japan
National Hospital Organization Sendai Nishitaga Hospital
Sendai, Japan
National Center of Neurology and Psychiatry
Tokyo, Japan
Academisch Ziekenhuis Leiden
Leiden, Netherlands
Stichting Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Donostia
San Sebastián, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
National Hospital for Neurology & Neurosurgery
London, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom